A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.

Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Drug: PF-04531083

• Registration Number: NCT01119235
• Lead Sponsor: Pfizer

Brief Summary

A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-19
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-05
• Last Update Posted: 2010-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Young
• Healthy volunteers

Exclusion Criteria

• Elderly volunteers
• Patients with any existing medical conditions considered likely to impinge on study execution

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: PF-04531083	PF-04531083	-
Cohort 1: PF-04531083	PF-04531083	-

Primary Outcome Measures

Name	Time	Method
concentration of PF-04531083 in blood just before dosing on the 8th day of the study	Days 1 and 8 of the study

Secondary Outcome Measures

Name	Time	Method
pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated.	Days 1, 8 and 14 of the study

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium